Focus on Rx and OTC Cough/Cold Products
The Rx cough market is about 25 million prescriptions per year. There are significant unmet needs in the Rx market, particularly the non-narcotic segment. Recent concerns about abuse and overdose associated with narcotics have produced some dramatic shifts in the cough market.
Ten years ago, the Rx cough market was about evenly divided between codeine and hydrocodone based products. As the chart below shows, prescriptions for hydrocodone have fallen with significant gains by benzonatate, the only non-narcotic Rx cough product.
It is our core belief that the prescription cough market is large and underserved with significant opportunities for new products, particularly non-narcotic products with patent protection.
As the figure below shows, there were approximately 26 million patient visits for cough in 2007. Since there are approximately 25 million cough medicine prescriptions are filled annually, the ratio of visits to prescriptions is high.
Physician Visits by Indication
Alitair’s development strategy emphasizes speed, low research & development costs, and efficient regulatory and marketing strategies. Alitair has had 6 pre-IND meetings with the FDA. These meetings can be used to gain valuable insights into FDA’s view of the proposed development path. As a result of these meetings, Alitair can develop its products using the 505(b)(2) route. No clinical efficacy trials and no safety or pre-clinical studies are required. Instead, Alitair will conduct pharmacokinetic studies (PK). The Company has written correspondence from the FDA supporting these points.
We believe the opportunity for our benzonatate product has an estimated sales potential approaching $100 million annually. Alitair also has a very strong patent portfolio around our benzonatate formulation as the chart below shows.